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Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial (MONICA)

Primary Purpose

Ruptured Cerebral Aneurysm, Unruptured Cerebral Aneurysm

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microsurgical clipping
Endovascular embolization
Sponsored by
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ruptured Cerebral Aneurysm focused on measuring Cerebral Aneurysm, Subarachnoid hemorrhage, Endovascular, Clipping, Embolization, Coiling

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with ruptured (acute SAH) or unruptured cerebral aneurysm who require surgical treatment (clipping and / or embolization)
  • Both male and female
  • Age from 18 to 80 years
  • Informed consent to participate in the study signed by the patient. If the patient cannot give consent, informed consent is signed by closest relatives or based on the results of a medical concilium
  • The patient (legal representative) agrees to a clinical assessment (examination and / or telephone visit) within 6 months and 12 months and to an angiographic control after 12 months
  • Patient has not previously been randomized to this or other ongoing study
  • Aneurysm has not previously been treated with endovascular embolization or microsurgical clipping

Exclusion Criteria:

  • The target aneurysm has been treated (embolization or clipping) before
  • Severe clinical condition of the patient (Glasgow coma scale <4, unstable hemodynamics)
  • Lack of signed informed consent
  • Severe medical or surgical comorbidity in which the patient's life expectancy is less than 2 years
  • Pregnancy, breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    IA-Microsurgical clipping group (ruptured aneurysms)

    IB-Microsurgical clipping group (unruptured aneurysms)

    IIA-Endovascular embolization group (ruptured aneurysms)

    IIB-Endovascular embolization group (unruptured aneurysms)

    Arm Description

    This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm

    This subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm

    This subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm

    This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm

    Outcomes

    Primary Outcome Measures

    modified Rankin Scale (mRS)
    Assessment of the clinical condition of patients will be carried out according to the modified Rankin scale (mRS). Primary Outcome Measure is modified Rankin Scale < or = to 2. mRS will be studied before surgery, after surgery, 6 and 12 months after discharge. Also the dynamics of changes in mRS compared with the baseline values will be analyzed. The null hypothesis is that no difference in outcome will be detected between the endovascular and surgical treatment arms. A statistically significant difference will then be considered evidence in favor of the alternative hypothesis, that one treatment is superior to the other.

    Secondary Outcome Measures

    Death
    Death associated with an underlying disease or its complication, or complication after surgery
    Grading the occlusion of treated cerebral aneurysms
    Assessed as total occlusion of the aneurysm or the presence of residual filling of the aneurysm
    Aneurysm recanalization
    Recanalization of the aneurysm after surgery will be assessed by cerebral angiography after 12 months
    Reoperations
    Additional operations on the target aneurysm after the initial intervention
    Periprocedural complications
    Any complications associated with surgical intervention: hematoma in the puncture area, dissection of arteries, postoperative intracranial hematoma, liquorrhea, postoperative meningitis, suppuration of postoperative stitches, neurological complications, etc.
    Stroke
    Ischemic or hemorrhagic stroke in the target artery

    Full Information

    First Posted
    September 8, 2020
    Last Updated
    September 8, 2020
    Sponsor
    Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04548856
    Brief Title
    Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial
    Acronym
    MONICA
    Official Title
    Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 14, 2020 (Anticipated)
    Primary Completion Date
    September 14, 2023 (Anticipated)
    Study Completion Date
    May 20, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Despite the active development of surgical methods of treatment (endovascular embolization and microsurgical clipping) of cerebral aneurysms, determining the indications and method of surgical treatment of cerebral aneurysms still causes debate in many cases. To a greater extent, this concerns the treatment of unruptured aneurysms. While there are a number of randomized trials of surgical treatment of ruptured cerebral aneurysms, there is currently no published randomized trial comparing surgical clipping and endovascular embolization of unruptured aneurysms. The purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular embolization of cerebral aneurysms (both ruptured and unruptured) in a prospective, randomized fashion.
    Detailed Description
    The study is planned to include 200 patients. Before randomization, patients will be stratified according to the presence or absence of aneurysm rupture in the acute period. The stratified patients will be randomized into two groups (100 to the microsurgical clipping group and 100 to the endovascular embolization group). Each group will be divided into 2 subgroups of 50 people each: the first subgroup includes patients in the acute period of aneurysm rupture, the second subgroup includes patients with unruptured aneurysms. Patients will be followed postoperatively, outcome endpoints will be assessed at discharge, 6 and 12 months. At discharge and after 6 and 12 months, patients will be assessed clinically using a modified Rankin scale (mRS). Cerebral angiography will be performed intraoperatively (endovascular group), after surgery (microsurgical group) and 12 months after discharge (both groups). Thus, the outcome of surgical treatment, including periprocedural complications and mortality, will be assessed both clinically and angiographically.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ruptured Cerebral Aneurysm, Unruptured Cerebral Aneurysm
    Keywords
    Cerebral Aneurysm, Subarachnoid hemorrhage, Endovascular, Clipping, Embolization, Coiling

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The stratified patients will be randomized into two groups (100 to the microsurgical clipping group and 100 to the endovascular embolization group). Each group will be divided into 2 subgroups of 50 people each: the first subgroup includes patients in the acute period of aneurysm rupture, the second subgroup includes patients with unruptured aneurysms.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    4 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IA-Microsurgical clipping group (ruptured aneurysms)
    Arm Type
    Other
    Arm Description
    This subgroup includes patients who underwent microsurgical clipping of an acutely ruptured cerebral aneurysm
    Arm Title
    IB-Microsurgical clipping group (unruptured aneurysms)
    Arm Type
    Other
    Arm Description
    This subgroup includes patients who underwent microsurgical clipping of unruptured cerebral aneurysm
    Arm Title
    IIA-Endovascular embolization group (ruptured aneurysms)
    Arm Type
    Other
    Arm Description
    This subgroup includes patients who underwent endovascular embolization of an acutely ruptured cerebral aneurysm
    Arm Title
    IIB-Endovascular embolization group (unruptured aneurysms)
    Arm Type
    Other
    Arm Description
    This subgroup includes patients who underwent endovascular embolization of unruptured cerebral aneurysm
    Intervention Type
    Procedure
    Intervention Name(s)
    Microsurgical clipping
    Intervention Description
    Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
    Intervention Type
    Procedure
    Intervention Name(s)
    Endovascular embolization
    Intervention Description
    Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.
    Primary Outcome Measure Information:
    Title
    modified Rankin Scale (mRS)
    Description
    Assessment of the clinical condition of patients will be carried out according to the modified Rankin scale (mRS). Primary Outcome Measure is modified Rankin Scale < or = to 2. mRS will be studied before surgery, after surgery, 6 and 12 months after discharge. Also the dynamics of changes in mRS compared with the baseline values will be analyzed. The null hypothesis is that no difference in outcome will be detected between the endovascular and surgical treatment arms. A statistically significant difference will then be considered evidence in favor of the alternative hypothesis, that one treatment is superior to the other.
    Time Frame
    6 and 12 months after discharge
    Secondary Outcome Measure Information:
    Title
    Death
    Description
    Death associated with an underlying disease or its complication, or complication after surgery
    Time Frame
    12 months
    Title
    Grading the occlusion of treated cerebral aneurysms
    Description
    Assessed as total occlusion of the aneurysm or the presence of residual filling of the aneurysm
    Time Frame
    12 months
    Title
    Aneurysm recanalization
    Description
    Recanalization of the aneurysm after surgery will be assessed by cerebral angiography after 12 months
    Time Frame
    12 months
    Title
    Reoperations
    Description
    Additional operations on the target aneurysm after the initial intervention
    Time Frame
    12 months
    Title
    Periprocedural complications
    Description
    Any complications associated with surgical intervention: hematoma in the puncture area, dissection of arteries, postoperative intracranial hematoma, liquorrhea, postoperative meningitis, suppuration of postoperative stitches, neurological complications, etc.
    Time Frame
    12 months
    Title
    Stroke
    Description
    Ischemic or hemorrhagic stroke in the target artery
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with ruptured (acute SAH) or unruptured cerebral aneurysm who require surgical treatment (clipping and / or embolization) Both male and female Age from 18 to 80 years Informed consent to participate in the study signed by the patient. If the patient cannot give consent, informed consent is signed by closest relatives or based on the results of a medical concilium The patient (legal representative) agrees to a clinical assessment (examination and / or telephone visit) within 6 months and 12 months and to an angiographic control after 12 months Patient has not previously been randomized to this or other ongoing study Aneurysm has not previously been treated with endovascular embolization or microsurgical clipping Exclusion Criteria: The target aneurysm has been treated (embolization or clipping) before Severe clinical condition of the patient (Glasgow coma scale <4, unstable hemodynamics) Lack of signed informed consent Severe medical or surgical comorbidity in which the patient's life expectancy is less than 2 years Pregnancy, breastfeeding
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Boris B Gegenava, Ph.D.
    Phone
    +79258383869
    Email
    gegenava_boris@dr.com

    12. IPD Sharing Statement

    Learn more about this trial

    Microsurgical Clipping and Endovascular Embolization Comparative Prospective Randomized Trial

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